Please note: As per company policy you need to use your own laptop for work.
12 Months
1005 onsite in 8010 Arco Corporate Drive Raleigh, NC 27617

Job Summary
The Strategic Partnering Infrastructure Lead (SPIL) partners with program and functional leaders within GCSO and the Patient Value Drivers to ensure that the processes that drive how work with the Strategic Contract Research Organization (CRO) partners are kept up to date to ensure operational delivery. The SPIL works closely with the Strategic Partnering Leads to ensure that lessons learned are incorporated into our CRO partnerships.

Responsibilities
Oversee and collaborate with internal functional stakeholders and CRO subject matter experts to inform the creation, revision, and update to the process map landscape, its associated specification documents, templates, tools and guidance which defines the framework in which the Clinical Strategic Partnership (CLIN SP)) functions. Represent Strategic Partnering when assessing the impact of new regulations (e.g., EU CTR, MDR, EU Data Protection) on CLIN SP business processes. Develop and oversee the onboarding programs for partner and staff working in the CLIN SP model. Oversee access management activities with strategic partners and relevant IT staff. Collaborate with various stakeholders, build and oversee the framework, vendors and solutions required to support managed access programs and other related post-trial access mechanisms

• Support Strategic Partnering Leads in the project management of operational and commercial steering committees as needed.
• Provide specialized thought leadership throughout life cycle of change initiatives.
• Cultivate an environment where associates respect and adhere to company standards of integrity and ethics by integrating these values into all programs and practices.
• Identify business improvement opportunities and lead creative solution ideation and implementation to improve efficiency and effectiveness of clinical development processes.
• Lead the development of New Operating Models by collecting business requirements and building processes cross-functionally with other subject matter experts.
• Coordinate Lessons Learned Meetings and ad hoc best practice sharing at appropriate timeframes to evaluate new models and ways of working to ensure constant improvement.
• Drive the development, implementation and ongoing management of the partner training programs and ensure compliance by monitoring metrics.
• Support Strategic Partnering Leads with Submission and Inspection Readiness activities.
• Lead Corrective Action and Preventative Action (CAPA) Plans that result from Internal Audits and Sponsor Inspections for key CLIN SP and non-preferred CRO processes. Travel requiring overnight stays, possibly global, is required.

Education – Bachelors

Competencies

• General knowledge of clinical development including, but not limited to:
• FDA/EMEA and other relevant regulations and guidance.
• ICH/GCP and regulatory environment.
• Development processes and roles/responsibilities.
• Well versed in the setup and conduct of clinical trials.
• Displayed experience in working within the framework of a strategic CRO relationship. Strong analytical and problem-solving skills.
• Strategic thinker with demonstrated ability to formulate a comprehensive yet agile. business strategy, ability to Distinguish proper balance between strategic and tactical thinking.
• Ability to work effectively as member or leader of virtual teams where membership may be across multiple departments, organizations and geographies.
• Innovative thinker, who leverages their broad knowledge and experiences to develop innovative solutions. Effective oral and written communication skills.
• Demonstrating listening skills resulting in a high level of partner satisfaction. Willing to travel, as necessary.
• 8 years of Clinical Operations and/or project management experience in roles of increasing responsibility with a track record of successful CRO relationship management.
• Bachelor s degree is required in any of several concentrations: science, finance, legal, business.
• Master s degree in the same concentrations is preferred.
• A scientific and business background is a plus. Good leadership skills, networking skills, and communication skills.
• Demonstrates clear and articulate verbal, written and presentation skills with good command of the English language and the appropriate comportment to represent at meetings. In all regions, fluency in multiple languages is a plus.